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High vs Standard Dose Interferon Alfa for Chronic Hepatitis C
NCT00004804Phase 3
Key facts
- Status
- Completed
- Start
- Aug 1993
- Sponsor
- National Center for Research Resources
- Modality
- Cytokines & Interferons
- Drugs
- interferon alfa
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 3, randomised trial of interferon alfa in hepatitis C (HCV) (2 arms), sponsored by National Center for Research Resources. Primary endpoint: Alanine Aminotransferase Normalization at 12 weeks. Started Aug 1993; status: completed.
02
Design
2 arms- Study design
- Randomized
High-dose IFN-A
High-dose interferon alfa administered subcutaneously for 12 weeks followed by stepwise reduction.
Standard-dose IFN-A
Standard-dose interferon alfa administered subcutaneously for 24 weeks.
03
Who it enrols
Patients with biopsy-proven chronic hepatitis C who are anti-HCV positive and HBsAg negative, without decompensated cirrhosis or other liver disease, and who have not received interferon for at least 1 year.
04
Endpoints
Primary
Alanine Aminotransferase Normalization
Secondary
Maintenance of Alanine Aminotransferase Normalization
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